Skip to content

FORE-SIGHT ELITE Module Tissue Oximeter

by Cas Medical Systems, Inc.

510(k) K180003

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK180003 Date10 May 2018ClearedStatusActive

Official records

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0835-2022 FDA Class II initiated 1 Mar 2022

    The StO2 values may be inaccurately low when using either the FORE-SIGHT ELITE Tissue Oximeter Module or the FORE-SIGHT ELITE Absolute Tissue Oximeter Monitor with the Fore-Sight Elite large sensor in certain somatic locations (arms and legs). While the StO2 absolute values are impacted, the directional trend remains accurate, but may have a larger magnitude change. Low StO2 values may lead to unintended or inappropriate treatment

Timeline

2 dated events

  1. Cleared FDA 510(k) K180003
  2. Recall initiated FDA recalls Z-0835-2022

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
MUD
Device class
Class II
Regulation
21 CFR Part 870.2700
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Fore-Sight Elite Module Tissue Oximeter is a non-invasive medical device designed to measure tissue oxygen saturation in brain tissue. Classified as an oximeter for tissue saturation, it employs near-infrared spectroscopy (NIRS) technology to assess cerebral oxygenation by projecting light through the scalp and skull into the brain via a disposable sensor.

This device is intended for use in clinical settings, such as intensive care units or operating rooms, where continuous or intermittent monitoring of cerebral oxygenation is required. Supplied as a reusable module with single-use disposable sensors, it operates without MRI compatibility restrictions. Authorized under FDA 510(k) clearance (K180003), it adheres to regulatory standards for Class II devices under 21 CFR 870.2700. Storage and handling follow manufacturer guidelines to maintain sensor integrity and device performance.

Devices cleared under K180003

4 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K180003
UDI-DISize and differences
FORE-SIGHT ELITE 01-06-1000
CAS MEDICAL SYSTEMS, INC.
01-06-100010609538610001 —On the market
FORE-SIGHT ELITE 01-06-1001
CAS MEDICAL SYSTEMS, INC.
01-06-100110609538610018 —On the market
FORE-SIGHT ELITE 01-06-1100
CAS MEDICAL SYSTEMS, INC.
01-06-110010609538611008 —On the market
HEMOSPHERE FORESIGHT MODULE HEMFSM10
Edwards Lifesciences LLC
HEMFSM10 / HEMFSM1000690103208573 —On the market

Similar devices

Other devices filed under FDA product code MUD (Oximeter, Tissue Saturation).

Other devices from Cas Medical Systems, Inc.

See all devices from Cas Medical Systems, Inc. →